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Sponsored by: |
Oswaldo Cruz Foundation |
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Information provided by: | Oswaldo Cruz Foundation |
ClinicalTrials.gov Identifier: | NCT00875251 |
Growth is traditionally used as a prognostic measure after admission to a neonatal intensive care unit (NICU).
Quality of neonatal intensive care is one of the factors determining the health and quality of life for those that survive, with the principal objective of increasing disability-free survival. Nowadays, there is some researches showing us that these preterm babies present a different body composition when they achieve term age compared with babies birth at term and this condition could be putting these babies in risk to metabolic syndrome early in adult age. The majority of infants born between 24 and 29 weeks of gestational age fail to achieve the mean birth weight for fetuses of the same gestational age, and many weigh below the 10th percentile at hospital discharge. The focus of this study is the growth and body composition of very low birth weight infants growing in the extrauterine environment. The central question is, when they reach the corresponding term weight, is the body composition of newborns growing outside of the uterus different from that of infants growing in the intrauterine environment? The investigators are also trying to validate 3 different methods to research body composition: DXA, air-displacement plethysmography and electric bioimpedance.
Condition | Intervention |
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Body Composition |
Device: Measurements of body composition |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Growth and Body Composition of Very Low Birth Weight Infants Compared With Infants Birth at Term |
Blood
Estimated Enrollment: | 60 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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term infants
Term infants from 2 days of life to 7 days of life without IUGR
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Device: Measurements of body composition
Measurements of body composition using 3 different devices: DXA, Bioimpedance measurements will be made with the RJL System (Quantum BIA 101Q equipment) and the Hydra multi-frequency equipment (Xitron technologies), air-displacement plethysmography in the PEA POD System (Life Measurement).
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preterm infants
very low birth weight infants before discharge
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Device: Measurements of body composition
Measurements of body composition using 3 different devices: DXA, Bioimpedance measurements will be made with the RJL System (Quantum BIA 101Q equipment) and the Hydra multi-frequency equipment (Xitron technologies), air-displacement plethysmography in the PEA POD System (Life Measurement).
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Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Preterm infants with birth weight less than 1500g
Term infants without IUGR
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Maria Elisabeth L Moreira | |
Rio de janeiro, Brazil, 22420040 | |
Brazil, RJ | |
Instituto Fernandes Figueira | |
Rio de janeiro, RJ, Brazil, 22520-040 |
Principal Investigator: | Maria E Moreira, MD | Oswaldo Cruz Foundation |
Responsible Party: | Oswaldo Cruz Foundation ( Maria Elisabeth Lopes Moreira - MD ) |
Study ID Numbers: | CAAE - 0292.0.008.000-05 |
Study First Received: | April 2, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00875251 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
body composition preterm infant anthropometry |
Body Weight Birth Weight |